Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

The 1st patient was enrolled on 31 Mar 2008. The last patient last visit was on 15 Dec 2009. 1901 patients (pts) were screened and 1217 pts were enrolled with the aim to randomize 816. 2 randomized pts were excluded since they received no medication. Eventually, 814 pts received medication. This study was conducted at 95 centers world-wide.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

For participants with a metformin dose of less than 1500 mg/day, a change in metformin dose in the past 8 weeks or on an Oral Anti-Diabetic (OAD), an 8-week metformin-only dose stabilisation period occurred. A 2-week placebo lead in period occurred after the dose stabilisation period or after enrolment if dose stabilisation period was skipped.

Reporting Groups

Description

Dapagliflozin Plus Metformin

Experimental dapagliflozin plus metformin

Glipizide Plus Metformin

Active Comparator glipizide plus metformin

Participant Flow: Overall Study

Dapagliflozin Plus Metformin

Glipizide Plus Metformin

STARTED

406 [1]

408 [2]

COMPLETED

322

314

NOT COMPLETED

84

94

Incorrect Enrollment

1

1

Adverse Event

33

19

Subject No Longer Meets Study Criteria

6

27

Withdrawal by Subject

23

32

Lost to Follow-up

3

3

Poor/Non-Compliance

5

1

Safety

1

0

Death

1

3

Various

11

8

[1]

Of the 406 randomized participants only 400 were included in the full analysis set.

[2]

Of the 408 randomized participants only 401 were included in the full analysis set.

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Full Analysis Set defined as all randomized participants (as randomized) who received at least one dose of double-blind study medication, who have a non-missing baseline value and at least one post-baseline efficacy value for at least one efficacy variable during double-blind treatment period.

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is less than or equal to 60 days.
The sponsor cannot require changes to the communication and cannot extend the embargo.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release
and can embargo communications regarding trial results for a period that is more than 60 days but less than
or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Restriction Description:
If an Investigator requests permission to publish data from this study any such publication is to be agreed with AstraZeneca (AZ) in advance. The investigator agrees to provide AZ as soon as possible with drafts of proposed publications. Unless otherwise agreed, AZ shall have a period of 60 days from receipt of the proposed final manuscript to review it and may within such time require that submission for publication of the manuscript be delayed in order for AZ to file patent applications.